Endoscopic Managment of Common Bile Duct Stones

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Best Practice & Research Clinical Gastroenterology Vol. 20, No. 6, pp. 1085 e1101, 2006 doi:10.1016/j.bpg.2006.03.002 available online at at http://www.sciencedirect.com

8 Symptoms, diagnosis and endoscopic management of common bile duct stones Grant R. Caddy*

MD, MRCP

Consultant Gastroenterologist

Tony C.K. Tham

MD, FRCP

Consultant Gastroenterologist Department of Gastroenterology, Ulster Hospital, Dundonald, Belfast, Northern Ireland, UK 

Bile Bile duct duct stones stones (BDS) (BDS) are often often suspec suspected ted on history history and clinic clinical al examin examinati ation on alone alone but sympto symptoms ms may may be variab variable le rangin rangingg from from asympt asymptoma omatic tic to compli complicat cation ionss such such as biliary biliary colic, colic, pancre pancreati atitis tis,, jaunjaundice dice or cholan cholangit gitis. is. The majori majority ty of BDS can be diagno diagnosed sed by transa transabdo bdomin minal al ultras ultrasoun ound, d, comput computed ed tomography, endoscopic ultrasound or magnetic resonance cholangiography prior to endoscopic or laparo laparosco scopic pic rem remova oval.l. Appr Approxi oximat mately ely 90% of BDS can be remove removed d follow following ing endosc endoscopi opicc retro retro-grade cholangiography (ERC) þ sphincterotomy. Most of the remaining stones can be removed using mechanical lithotripsy lithotripsy.. Patients Patients with uncorrected uncorrected coagulopat coagulopathies hies may may be treated treated with ERC þ pneuma pneumatic tic dilata dilatatio tion n of the sphinc sphincter terof of Oddi. Oddi. Shockw Shockwav ave e lithot lithotrip ripsy sy (intra (intraduc ductal tal and extraextracorporeal) and laser lithotripsy have also been used to fragment large bile duct stones prior to endoscopic removal. The role of medical therapy in treatment of BDS is currently uncertain. This review focuses on the clinical presentation, investigation and current management of BDS. Key Key words: bile duct stones; stones; choledocho choledocholithi lithiasis; asis; ERCP; ERCP; Endoscopic Endoscopic retrograd retrograde e cholangiocholangiograph graphy; y; sphinc sphincter teroto otom my; endosc endoscopi opicc biliary biliary stenti stenting; ng; lithot lithotrip ripsy; sy; ESWL; ESWL; MRCP; MRCP; mechan mechanica icall lithotripsy; chemical dissolution; ursodeoxycholic acid; review.

SYMPTOMS AND SIGNS OF COMMON BILE DUCT STONES

The symptoms and signs of common bile duct stones (CBDS) are variable and can range from being completely asymptomatic to complications such as biliary colic, jaundice, cholangitis or pancreatitis. Whilst complications of retained bile duct stones (BDS) are common, a proportion of CBDS remain asymptomatic and do not result in any * Corresponding author. Tel.: þ44 28 90484511x2479; Fax: þ44 28 90564785. E-mail addresses: [email protected]  (G.R. Caddy), [email protected]  [email protected] (T.C.K. (T.C.K. Tham). 1521-6918/$ - see front matter

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2006 Elsevier Ltd. All rights reserved.

1086 1086 G. R. R. Caddy Caddy and and T. T. C. K. Tham Tham

complications. However, the natural history of asymptomatic BDS is difficult to determine. Studie Studiess have estimated the prevalence of  asymptomatic  BDS to be between 5.2% and 12%.1e4 The natural history of  asymptomatic  BDS appears to be more benign than that of  symptomatic  BDS.5 A study by Millbourn of 38 patients presenting with symptomatic  BDS, who were unfit for surgery or refused surgery, were followed for 6 months to 13 years. Forty-five per cent of the patients became asymptomatic but 55% developed complications such as biliary colic, jaundice and cholangitis. 6 More recently Johnson and Hosking reported similar outcomes with over 50% of patients with retained duct duc t stones developing symptoms over time with 25% developing serious complications. 7 Conversely, a study by Murison and colleagues randomised patients undergoing cholecystectomy, but without symptoms of bile duct stones, to intraoperative or no intraoperative cholangiography. Twelve per cent of patients in the cholangiography group were discovered to have bile duct stones. It was assumed that a similar percentage of  patients in the group without cholangi cholang iography had stones, but no patients developed symp sympto toms ms in in over over 3 year yearss of follow-up. f follow-up.2 We found similar similar results results in our local populatio population n 8 in a non-randomised study. A co comm mmon on pres presen enta tati tion on of CBDS CBDS is bili biliar aryy co colilic. c. The The pain pain is ofte often n situ situat ated ed in the the righ rightt hypochondrium or epigastrium lasting 30 min to several hours. Associated symptoms with nausea and vomiting are common. Biliary colic typically is not eased by change in body position and is not specifically related to food intake. The pain is thought to be caused by distension of the common bile duct due to an increase in pressure caused by partial or complete obstruction by a CBDS. One study has suggested that presentation tion of CBDS CBDS may may de depe pend nd on the the numb number er of ston stones es situ situat ated ed in the the CBD CBD (e.g (e.g.. one one to thre threee stones stones more more likely likely associa associated ted with with cholan cholangit gitis, is, biliary biliary colic colic and higher higher biliru bilirubin bin levels levels than than patients patients presen presented ted with with four four or more more ston stones es who who we werre more more lik likely ely to pres presen entt with with pain pain-9 less jaundice). In additio addition n to the numbe numberr of stones, stones, the diame diameter ter of CBDS CBDS is also also important tant.. The The like likelih lihood ood of ston stones es pass passin ingg spon sponta tane neou ously sly may may be de depe pend nden entt on size. size.10 Stones up to 8 mm may may pas passs with withou outt pro probl blem emss as sugg sugges este ted d by a stud studyy in whic which h bile duct stones were shown to pass spontaneously spontaneously when ERCP was later performed.11,12 When a stone becomes impacted in the bile duct, obstructive jaundice ensues. Often the obstruction of the bile duct is incomplete but complete obstruction may occur occ ur.. Fre Freque quentl ntlyy the obstru obstructe cted d bile bile become becomess infect infected ed result resulting ing in cholan cholangiti gitis. s. CBDS often contain bacteria embedded within their matrix. When obstruction of  the bile duct occurs, the rise in biliary pressure results in the translocation of bacteria from the bile duct to the blood-stream. Approximately one-fifth of patients presenting with cholangitis from from CBDS will have a bacteraemia, usually with gram negative organisms being cultured.13 The symptoms of cholangitis are described by Charcot’s triad of   jaundice, fever and pain in up to 75% of patients. However, in a minority minority of patients (12%) pain alone may may be the only presenting presenting feature of cholangitis cholangitis.. 14 Prolonged Prolonged biliary obstruction results in secondary biliary cirrhosis after approximately 5 years. 15 Between 4% and 8% of patients with gallstones will develop gallstone pancreatitis secondary to migratory gallstones. 16 Developing gallstone pancreatitis is more likely with smaller stones than with larger stones. In a study by Venneman, it was found that patients presenting presenting with gallstone gallstone pancreatitis pancreatitis had mean diameter diameter bile duct stone size of 4 of  4 mm compared to that of 9 mm for patients presenting with obstructive jaundice.17 The majority of these of  these patients will have a self limiting disease but mortality still remains around 10%.18 There have been several scoring systems devised to predict the severity sev erity of pancreatit pancreatitis is including including the Ranson Ranson system, system, modified modified Imrie system, Apache II score score and Baltha Balthazar zar grading grading syste system. m. The hese se scor scorin ingg syst system emss are are base based d on or orga gan n 19,20 dysfunction and local complications.

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Practice points   

The natural history of  asymptomatic  bile duct stones appears to be more benign than that of  symptomatic  bile duct stones Up to 50% of patients presenting with symptomatic bile duct stones will develop complic complicati ations ons such such as bilia biliary ry colic, colic, chola cholangi ngitis tis,, pancr pancreat eatiti itiss or jaundi jaundice ce if left left in situ The symptoms of cholangitis are described by Charcot’s triad of jaundice, fever and pain in up to 75% of patients. However, in a minority of patients (12%) pain alone may be the only presenting feature of cholangitis

CLINICAL DIFFERENTIAL DIAGNOSIS

The differential diagnosis of CBDS will be dependant on the clinical presentation.  Jaundice with or without pain

The differential of patients presenting with obstructive jaundice include bile duct stricture turess (both (both be beni nign gn and and malig maligna nant) nt).. Beni Benign gn stric strictu ture ress ofte often n resu result lt from from prev previou iouss episodes of pancreatitis or cholangitis, whilst malignant strictures can be due to intrinsic obstruction due to a cholangiocarinoma or extrinsic compression due to pancreatic atic or gall gallbl blad adder der carc carcin inom oma. a. The The pres presen ence ce of jaun jaundi dice ce with with pain pain sugg sugges ests ts the the presence of a bile duct stone while painless jaundice is more likely to be associated with biliary strictures. Courvoisier’s law states that in the presence of jaundice, a palpable gallbladder is likely to be due to malignant obstruction of the bile duct rather than choledocholit choledocholithiasi hiasis. s. Other differenti differentials als include include sclerosing sclerosing cholangitis, cholangitis, parasitic parasitic infection of the biliary tree, primary biliary cirrhosis, alcoholic liver disease and bile duct injuries during laparoscopic cholecystectomy, e.g. inadvertent ligation of biliary structures. Biliary colic

Differential diagnoses of patients presenting with pain caused by CBDS without biliary obstruction (biliary colic) include cholecystitis, sphincter of Oddi dysfunction, acute pancreatitis, peptic ulcer disease, duodenitis, oesophageal spasm and inferior myocardial infarction. Pancreatitis

The differential differential diagnosis of acute pancreatitis pancreatitis includes a perforated perforated gastric or duodenal ulcer, mesenteric infarction, strangulating intestinal obstruction, ectopic pregnancy, dissecting aneurysm, biliary colic, appendicitis, diverticulitis, inferior myocardial infarction and haematoma of abdominal muscles or spleen. Abnormal cholestatic liver function tests

The differential includes mechanical obstruction caused by biliary strictures (benign and malignant e as above), ampullary carcinoma, primary biliary cirrhosis, sclerosing

1088 1088 G. R. R. Caddy Caddy and and T. T. C. K. Tham Tham

cholangiti cholangitis, s, medication medication induced, induced, congenital congenital ductopenic ductopenic syndromes, syndromes, granulomato granulomatous us hepatitis, malignant infiltration of the liver e.g. lymphoma, amyloidosis, alcoholic liver disease and non alcoholic fatty liver disease (NAFLD).

DIAGNOSTIC DIAGNOSTIC INVESTIGATIONS INVESTIGATIONS Laboratory tests

Patients presenting with CBDS often have cholestatic liver function tests (LFT’s). In the study by Anciaux, elevated serum gamma glutamyl transpeptidase (GGT) and alkaline phosphatase (ALP) were the most frequent biochemical abnormalities in patients with wi th symptomatic choledocholithiasis (increased in 94% and 91% of cases, respectively). 14 Serum bilirubin levels may be markedly elevated depending on whether the obstruction of the bile duct is complete complete or incomplete. incomplete. In the same study by Anciaux, bilirubin levels levels and transa transamin minase asess wer were e found found to dec decrea rease se ove overr the subseq subsequen uentt 10 days days in patients with CBDS following admission to hospital. There have been many studies attempting to predict the likelihood likeli hood of concomitant CBDS in patients going on to have laparoscopic cholecystectomy. 21e28 In a retrospective study by Onken and colleagues in 465 patients with confirmed choledocholithiasis at time of cholecystectomy, multivariable analysis identified serum bilirubin, AST, and ALP, in addition to co common mmon bile duct diameter and age as independent predictors of  27 choledocholithiasis. Most of the studies have emphasised that laboratory investigations must be used in addition to other imaging modaslities to predict the likelihood of CBDS and the multivariate analysis model m odelss have found a dilated bile duct as an independent variable in predicting CDBS. 25e28

Transabdominal ultrasonography

Transabdominal ultrasonography (TUS) remains the first line radiological investigation in patients with suspected CBDS. TUS has a high sensitivity of detecting both intrahepatic and extrahepatic biliary dilatation. In the study by Stott and colleagues, the sensit sensitivi ivity ty of TUS compar compared ed to endosc endoscopi opicc retro retrogra grade de cholangiopancreatography (ERCP) in detecting common bile duct dilatation was 96%. 29 However, the sensitivity of TUS in detecting choledocholithiasis is much lower with sensitivities of  between between 25% and 63% when compared to endoscopic ultrasound (EUS) and ERCP. 30,31 Although with a specificity of  approximately 95%, TUS remains an extremely useful test if CBDS are detected. 30 A negative egative TUS in a patient with suspected choledocholithiasis does not rule out CBDS. 32

Computed tomography

Convention Conventional al computed computed tomograph tomographyy (CT) studie studiess have found found sensiti sensitivit vities ies betwe between en 70% 33e35 and 90% in the detection of choledocholithiasis. The use of unenhanced unenhance d helical helical CT 36e39 for detect detection ion of choled choledoch ocholit olithia hiasis sis has similar similar sensiti sensitivit vities ies of  67e88%. Oral 36 enhanced CT cholangiography has an increased sensitivity of 92%.

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EUS

EUS is an an accurate accurate test for detection of CBDS, with a sensitivity range between 94% 40,41 and 98%. Due to a significant complication rate associated with ERCP, the decision to use EUS to detect choledocholithiasis depends on the probability of CBDS in symptomatic patients. The probability of CBDS being detected can be stratified into low, intermediate or high probability based on clinical, biochemical and imaging criteria that have already been discussed. The use of EUS may be best suited for patients that fall into the intermediate risk category and thereby reducing the risk to the patient of pancreatitis and cholangitis that could potentially occur following ERCP. Patients in the low risk category should be referred for laparoscopic cholecystectomy and patients in the high risk category should undergo ERCP þ sphincterotomy or cholecystectomy þ intr intraop aopera erative tive cholan cholangio giogra gram m with with lapar laparosc oscopic opic extrac extraction tion of any 42 stones detected. Magnetic Resonance Cholangiography (MRC)

Magnetic Resonance Cholangiography (MRC) has become an accepted method of  imaging the bile duct with a high sensitivity and specificity for choledocholithiasis. One such study by Ainsworth and colleagues found the accuracy rates of detection of choledocholithiasi choledocholithiasiss comparable between EUS and MRC (accuracy rate 93% and 91%, respectively).43 In addition, several studies have found MRC to be comparable to ERCP. The study by Laokpessi and colleagues found both MRC and ERCP comparable in detecti detection on of CBDS (sensitivity and specificity 93% and 100%; 94% and 100%, 44 respectively). A recent NIH consensus statement found that ERC, MRC and EUS were comparable in the their ir sensitivities, specificities and accuracy rates for detection 45 of choledocholithiasis. Endoscopic Endoscopic retrograde retrograde cholangiograph cholangiography y (ERC)

ERC has sensitivities between 90% and 95% in detecting choledocholithiasis. 44,46 It is often the gold standard test to which other modalities are compared in the detection of CBDS. The benefit of ERC is that therapeutic removal of the stone(s) can be performed formed immedia immediatel telyy. Howev However er,, the risks risks of ERC have have bee been n well well docume documente nted d and therefore ERC is recommended in patients with a high probability of CBDS. In patients with an intermediate probability of CBDS, other imaging modalities should be considered as discussed above.

Practice points 



Elevated GGT and ALP were the most frequent biochemical abnormalities in patients with symptomatic choledocholithiasis, increased in 94% and 91% of  cases, respectively. The The sens sensit itiv ivit ityy of TUS TUS in de dete tect cting ing co comm mmon on bile bile duct duct dila dilata tati tion on wa wass 96% 96% but but the the sens sensit itiv ivity ity of TUS TUS in de dete tect cting ing chol choled edoc ochol holit ithi hiasi asiss is much much lowe lowerr (25e63%)

1090 1090 G. R. R. Caddy Caddy and and T. T. C. K. Tham Tham

     

Conventional CT have found sensitivities between 70% and 90% in the detection of choledocholithiasis Oral enhanced CT cholangiography has an increased sensitivity of 92% EUS is an accurate test for detection of CBDS, with a sensitivity range between 94% and 98% The The accu accura racy cy rate ratess of de dete tect ctio ion n of chol choled edoc ocho holilithi thias asis is are are co comp mpar arab able le between EUS and MRC ERC has sensitivities between 90% and 95% in detecting choledocholithiasis NIH consensus statement found that ERC, MRC and EUS were comparable in thei theirr sens sensit itiv ivit itie ies, s, spec specifi ifici citi ties es and and accu accura racy cy rate ratess for for de dete tect ctio ion n of  choledocholithiasis

IS THERE ALWAYS AN INDICATION TO TREAT CBD STONES?

As previously discussed, CBDS detected in symptomatic patients, have a high rate of  complications if left in situ (approximately 50% of patients will subsequently develop  jaundice, cholangitis, biliary colic or pancreatitis). The true natural history of asymptomatic bile duct stones is unknown but they appear to cause fewer complications than CBDS detected in symptomatic patients. In contrast, in asymptomatic gallstones , a cholecystectomy would not be recommended, as the cumulative risk of developing symptoms is not as great as that of asymptomatic CBDS. In addition, complications will develop after the emergence of symptoms. However, with asymptomatic CBDS, complicat plications ions usuall usuallyy dev develo elop p before before sympto symptoms. ms. In an increa increasin singg litigio litigious us society society,, the majori majority ty of gastr gastroen oenter terolo ologis gists ts would would rec recomm ommend end attemp attempted ted remova removall of CBDS CBDS once detected for fear that any subsequent complications that may ensue may be as a consequence of leaving the stones in situ. Small stones may pass spontaneously as previously mentioned. There may be clinical situations in which the risk of performing an ERC to remove identified CBDS may outweigh the benefits. For example, patients with a short life expectancy e.g. severe end stage dementia or with severe co-morbidity making ERCP hazardous. In these situations the risk assessment is the duty of the endoscopist and it may be deemed appropriate not to perform ERC. The decision making process should be carefully explained and documented with the patient (if possible) and family members. ROLE ROLE OF MEDICAL MEDICAL THERAP THERAPY? Y?

The role of medical therapy will discuss the role of ursodeoxycholic acid (UDCA). The role of other non-surgical treatments of CBDS such as extracorporeal shockwave lithotripsy (ESWL) will be discussed below. The use of UDCA (and chenodeoxycholic acid) has only been shown to dissolve cholestero cholesteroll containing containing stones. stones. However However,, approxim approximately ately 85e95% of patients in the Western World will have cholesterol stones. The first first report of using bile salt acids to dissolve cholesterol stones was reported in 1927.47 It wasn’t until half a century later later that that larger larger studie studiess wer were e perfor perform med to investigate the use chenodeoxycholic 48 acid on the dissolution of gallstones. To date the majority of these studies have been be en pe perf rfor orme med d on patie patient ntss with with galls gallsto tone ness rath rather er than than on pati patien ents ts with with CBDS CBDS.. The studies that have been performed in this patient group contain small numbers

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of patients and are statistically underpowered. Salvioli and colleagues investigated the effect of UDCA (12 mg/kg) on 28 patients with radiolucent CBDS compared with placebo. None of the patients in the placebo group had resolution of their CBDS du ring ring a 24-month period follow-up compared with seven patients in the UDCA group. 49 UDCA is often used in association with ERC and biliary stent insertion for failed extr ex trac actio tion n of CBDS CBDS.. John Johnson son and and colle colleag ague uess stud studie ied d 24 pati patien ents ts with with diffi difficu cult lt to extract CBDS and randomised the patients to either UDCA þ stent or stent alone with follow up ERC and attempted stone removal. In the UDCA group, 90% of the patients subsequently had ductal clearance at repeat ERCs compared w ith none of  the patients in the stent alone group at the end of the study period. 50 Ros and colleagues studied a group of patients with recurrent pancreatitis caused by microlithiasis and found that patients treated with UDCA (10 mg/kg) eliminated gallbladder microlithiasis and reduced the episodes of further pancreatitis. Continuin Continu ingg therapy with UDCA appeared to prevent recurrence of gallbladder microlithiasis. 51 Curren Currently tly there there are no large large random randomised ised contr controlle olled d trials trials provi providin dingg convin convincin cingg evidence at this time that UDCA has a role in the management of CBDS. However, in view of the relative few side effects and good safety profile, gastroenterologists will continue to use UDCA in patients with difficult to extract CBDS. Larger and more robust studies are required to determine any overall benefit of UDCA on retained CBDS.

Research agenda  

Currently there are no large randomised controlled trials providing convincing evidence at this time that UDCA has a role in the management of CBDS The role of UDCA needs to be defined in the treatment of CBDS

ERC (SPHINCTEROTOMY OR PNEUMATIC DILATATION)

Endoscopic biliary sphincterotomy (EST) at ERC was first described in 1974 and was initially advocated for elderly patients or patients with other co-morbid illness excluding them from surgical management. However, since this time, EST has become widespread in the practice for the removal of CBDS. The complications of EST have been previously previously well described. described. The use of EST, EST, particularly particularly in younger younger patients, led to concern over the long term sequelae of a disrupted sphincter of Oddi caused by chronic enteric-biliary reflux. However, a review suggests suggests that this theoretical risk of cholangitis is not apparent in long term studies. 52 Endosc Endoscopic opic balloon balloon dilata dilatation tion (EBD) (EBD) of the sphinct sphincter er had previo previously usly bee been n perperforme formed d in the the 1980 1980ss but but had had subs subseq equen uentl tlyy lost lost favo favour ur in clin clinic ical al prac practic tice e due due to reports reports of increa increased sed compli complicat cations ions (mainly (mainly that that of pancr pancreat eatiti itis). s). Howev However er,, sev severa erall more more rec recent ent studie studiess had sugges suggested ted that that the original original risk risk of post-E post-EBD BD pancre pancreati atitis tis was overestimated due to recruitment of patients with sphincter of Oddi (SOD) dysfunction function (a group with a known increased increased risk of post-ERC post-ERC pancreatit pancreatitis). is). Subsequently Subsequently there have been several randomised controlled trials comparing EBD against EST. 53e60 These stu studies dies have been recently been reviewed in a meta-analysis by Baron and col61 leagues. In their meta-analysis (incorporating eight randomised prospective studies and over 1000 patients) they found the overall similar rate of complications (10.3%

1092 1092 G. R. R. Caddy Caddy and and T. T. C. K. Tham Tham

and 10.5%, respectively). However, the rates of pancreatitis were significantly higher for for the the EBD EBD grou group p (7.4 (7.4% % versu versuss 4.3% 4.3%)) but but bleed bleedin ingg co comp mplilica cati tion onss we were re redu reduce ced d (0% versus 2%). Other complication rates of infection and perforation were similar between the two groups. Primary clearance of the bile duct was less successful using EBD compared to EST (70% versus 80%), and the use of mechanical lithotripsy was more common (21% versus 15%). A further randomised control trial, not included in the meta-analysis, comparing the short term complications of EBD versus EST again confirmed an increase rate of  pancreatitis with EBD versus EST (15.4% and 0.8%, respectively). 62 The rate of post EST pancreatitis in this study was lower than that expected, however. Patients were found to have more frequent invasive procedures, longer hospital stay and more missed days off work/normal activities of daily living in the EBD group. EBD has been advocated in patients with coagulopathies where the risk of bleeding from sphincterotomy would be hazardous. However, if the coagulopathy cannot be corrected prior to the ERCP procedure then a biliary stent is a safe alternative and is our preference over EBD. Following endoscopic sphincterotomy (or balloon dilatation), CBDS are removed using a Dormia-type basket of a balloon catheter. Using either of these techniques stones can be removed form the bile duct in about 90% of patients.

Practice points    

In a meta-anal meta-analysis ysis (incorporating (incorporating over 1000 patients), patients), the overall overall complicatio complication n rate between EST and EBD were similar (10.3% and 10.5% respectively) However, rates of pancreatitis are significantly higher for EBD compared to EST (7.4% versus 4.3%) Bleeding complications were reduced in EBD compared to EST (0% versus 2%). Patients Patients were found to have have more frequent frequent invasive procedures, procedures, longer hospital stay and more missed days off work/normal activities of daily living in the EBD group compared to EST

MECHANICAL LITHOTRIPSY

Stone removal from the common bile duct may be technically difficult due to factors such as the size of the stone ( >2 cm), impaction of the stone in a non-dilated bile duct, stones above a bile duct stricture or a narrowed retro-pancreatic portion of the distal CBD. In these circumstances, mechanical lithotripsy (ML) is commonly used. The standard ML device is a basket inserted through a plastic and then a metallic sheath, which is inserted through the scope. The Olympus BML range and Monolith lithotriptor, (Microvasiv cro vasive e Corp) are amongst the most commonly used lithotriptor lithotriptor devices. devices. The CBD stone is engaged with an open basket and the metallic sheath can then be advanced up into the bile duct to meet the basket resulting in crushing of the stone. Often the wires of the basket can become deformed after several ‘crushes’ and the ML device may need to be removed to reset the wires back into their standard position. The use of ML was described in 1982 as a method of successfully removing large CBDS.63 Bile duct clearance rates using ML have been reported to be between 68% and 98%.64e71 In a retrospective series of 163 patients to investigate a range of parameters that may be important in failure to remove CBDS, Cipolletta and colleagues

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found that size of the stone was the only factor important in failure of bile duct clearance using ML. 66 They found that bile duct clearance rates were 90% for stones with a diameter less than 10 mm compared to 68% for those greater than 28 mm in diameter. Subsequently a prospective study by Garg and colleagues only identified impaction of CBDS in the bile duct as the only important factor in failure of a ML. This study did not find the size of CBDS as a significant factor in failure of a ML in the removal of difficult CBDS.65 The impaction of the stone led to an inability to pass the basket proximal to the stone or a failure to open fully around the stone to allow it to be grasped. Often if there is little space between the stone and bile duct wall, the basket will not fully open and therefore not be able to engage the stone. It has been found useful in these circumstances to insert the metall met allic ic sheath up into the bile duct 72 and to rotate the basket to try to grasp the stone. Even if the stone is partially engaged, the stone can be fragmented and successfully removed.

Practice points 

 

The removal of CBDS may be technically difficult due to factors such as the size of the stone (>2 cm), impaction of the stone in a non-dilated bile duct, stones above a bile duct stricture or a narrowed retro-pancreatic portion of  the distal CBD Bile duct clearance rates using ML have been reported to be up to 98%. Impaction of CBDS in the bile duct is an important factor in failure of a ML to remove stones

Shoc Shockk wa wave vess can can be gene genera rate ted d with with intr intrae aend ndos osco copi pica call prob probes es by dire direct ct co cont ntac actt (ele (elecctrohydraulic lithotripsy) or a pulsed dye laser (laser lithotripsy), or outside the bile duct using an extracorporeal lithotriptor. These techniques are generally reserved for patients in whom stones cannot be removed with conventional techniques due to factors such as large size of the stones, impacted stones or the presence presence of a biliary stricture. stricture. INTRAENDOSCOPICAL LITHOTRIPSY Pulsated laser lithotripsy

Laser lithotripsy uses an amplified light energy, at a particular wavelength, which is focused into a single beam and directed onto a stone within the bile duct. This causes plasma formation on the surface of the stone, allowing more absorption of laser light, and results in an acoustic shockwave that can fragment the stone. Laser lithotripsy can be performed under direct vision using cholangioscopy using mini scopes or can be performed under fluoroscopic control using standard equipment. More recently the development of software coupled to the laser allows differentiation of light reflected back from bile duct epithelium compared to light reflected back from a stone. This causes a discontinuation of the laser pulse, and reduces any potential thermal injury to the epithelium. The use of this software allows the safe use of laser lithotripsy under fluoroscopic fluoroscopic control control and avoids avoids the need for lithotripsy lithotripsy to be performed under direct vision.

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The experience of laser lithotripsy has been limited to a few centres and the majority of the published literature on its use has been in a small number of patients in non-randomised studies. Despite these limitations the success rate of duct clearance for retained retained bile bile duct stones using laser lithotripsy in these studies is between 73e84 64% and 97%. In a randomised trial comparing laser lithotripsy versus extracorporeal poreal shockwav shockwavee lithotripsy (ESWL), laser lithotripsy lithotripsy was found to be more effective effective in clearing clearing the bile duct (29/30 patients) compared to ESWL group (22/30 patients) p < 0.05.85 Electrohydraulic lithotripsy

Electrohydraulic lithotripsy (EHL) uses direct high voltage to generate a shockwave, through a liquid medium, to fragment the BDS. B DS. The procedure has been performed successfully under cholangioscopic guidance86,87 or under fluoroscopic control using a balloon catheter.88 The advantage advantage of direct direct visualisation visualisation is to control the shockwav shockwavee being applied to the stone rather than on the ductal wall and thereby potentially reduc reducing ing compli complicat cation ions. s. Howev However er,, the disadv disadvant antage age is the cost, cost, and the experti expertise se requir required ed in cholan cholangio giosco scopic pic techniq techniques ues.. In ear earlie lierr studie studies, s, a stone stone fragm fragmenta entatio tion n 89,90 rate of approximately 80% was achieved using EHL. In the prospective open study by Adamek and colleagues, a stone fragmentation rate of 93% was achieved achieved and they were able to remove all stones from the bile duct in 74% of patients. 86 In a small randomised trial comparing extracorporeal shockwave lithotripsy versus EHL, no difference en ce wa wass de demo mons nstr trat ated ed in ston stone e free free rate ratess of the the bile bile duct duct at the the en end d of each each treatment. In addition, both groups group s of patients patients required required additional additional endoscopic endoscopic proceproce91 dures to remove residual stones. Hui and colleagues found a lower incidence of  complic complicati ations ons,, particu particular larly ly cholan cholangit gitis, is, in a small small prosp prospect ective ive study study of 36 patien patients, ts, comparing double pigtail stent inse in sertion rtion versus EHL therapy in difficult to remove 92 CBD stones (63.2% versus 7.7%). In summary, the use of EHL has been used successfully in patients with difficult to remove CBD stones but its use is limited to specialised centres. In addition, most of the published studies are in a small number of  patien patients ts and subjec subjectt to bias, bias, making making eviden evidence ce based based rec recomm ommend endati ations ons on its use limited. STENTING AS DEFINITE TREATMENT OF BILE DUCT STONES?

Insertion of an endoprothesis may be required on a temporary basis for difficult to retrieve CBDS. Studies have shown that the majority of CBDS reduce in size following stenting and therefore should be easier to remove at repeat ERCP. 93 However, insertion of an endoprothesis as a definitive treatment of CBDS, without any further subsequent intervention, may be considered but should be limited to patients with severe co-morbid illness. Any such illness should make any subsequent ERC procedures hazardous to be performed and therefore best avoided. The decision regarding a patient’s fitness to undergo an ERCP is that of the endoscopist performing the procedure but an anaesthetic assessment may also be useful in the decision making process. There have been several studies investigating the role of stent insertion as the sole treatment of CBDS that could not be removed at ERC. In the study by Bergman and colleagues, 58 of 117 patients had permanent biliary stent insertion as their treatment for for CBDS CBDS (i.e. (i.e. ex expe pect ctan antt mana manage geme ment nt and and sten stentt ex exch chan ange ge only only if co comp mplic licat atio ions ns

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occurred). Sixty percent of these patients were alive at 2 years of follow up and of  these these 70% wer were e symptom symptom free. free. Howev However er,, ove overal ralll the compli complicat cation ion rate rate was 40% and the mortality rate related to complications of the biliary stent was 16%. Cholangitis and jaundice were felt to be the cause attri butable butable to the death of these patients and occurred after a median time of 42 months. 94 These results are similar to a study by De Palma and colleagues, which followed up 49 patients with stent insertion for irretrieva irretrievable ble CBDS. Their results found a 40% late complic complication ation rate and 6% mortality 95 related to biliary sepsis over a 3-year follow-up period.  Jain and colleagues carried out a prospective study on 20 patients with difficult to extract CBDS (mean diameter of stone was 1.7 cm). In each case a 7F pigtail stent was inserted and ERC repeated at 6 months. In 20% of patients the stones had fragmented and allowed balloon clearance clearance of the duct. However, in 35% of patients the duct had cleared spontaneously. 96 There is a potential advantage of pigtail stents over straight stents in that the duodenal portion of the stent comes out at an angle and may keep the biliary orifice open more effectively. If the stent becomes occluded after several months, it still has the potential to keep the CBDS from impacting. Pigtail stents also have a lower rate of stent migration. The evidence for the use of pigtail over straight stents for definitive treatment of  CBDS is however limited. In the study by Hui and colleagues, as previously mentioned, there was a lower incidence of cholangitis and mortality mortality in a small study comparing summary,, where facilities facilities exist, double pigtail stent insertion versus EHL therapy. 92 In summary alternative forms of treatment should be considered in high risk patients with retained CBDS such as lithotripsy. However, long term stenting is an alternative in patients with a poor life expectancy. EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY

Extr Extrac acor orpo pore real al shoc shockwa kwave ve lith lithotr otrip ipsy sy (ESW (ESWL) L) wa wass first first used used tre treating ting gallst gallstone oness 97 in 1980 1980ss follo followi wing ng its its succ succes essf sful ul use use in frag fragme ment ntin ingg rena renall calc calcul uli.i. Shock wav waves es are generated outside the body using electrohydraulic, electromagnetic or piezoceramic shockwave systems. First generation lithotriptors required patients to be immers mersed ed in a wa wate terr bath bath and and ofte often n requ requir ired ed gene genera rall anae anaest sthe hesi sia. a. Subs Subseq eque uent nt generation of lithotriptors do not require immersion in a water bath and can be performed under intravenous sedation. sedation. Complete Complete duct clearance of CBDS following 97e100 ESWL range between 83% and 93%. The majority of patients will require endoscopic extraction of the bile stone fragments following ESWL, although approxappro ximately 10% of stones may subsequently pass spontaneously following treatment. 98 Loca Localilisa sati tion on of CBDS CBDS amen amenab able le to ESWL ESWL is pe perf rfor orme med d unde underr fluor fluoros osco cop py or ultrasound. In a small prospective randomised trial comparing ESWL to EHL, no significant difference difference in ston stone e frag fragme menta ntatio tion n rate ratess or final final bile bile duct duct clea cleara ranc nce e wa wass de demo monn91 strated. A larger prospective non-randomised trial by the same authors found similar results of final bile duct clea cl earance rance rates between the two treatment modalities 86 (79% versus 74%, respectively). Comparison studies between ESWL and laser lithotripsy as mentioned previously have demonstrated significantly higher final bile duct cleara clearance nce rates, rates, fewer fewer additio additional nal interve interventi ntions ons required equired followi following ng treatm treatment ent and 85,101 shorter duration of treatment for laser lithotripsy. The main morbidity associated with ESWL is sepsis due to bacteria being released into the bloodstream during shoc shockw kwaave trea treatm tmen ent. t. PrePre-pr proc oced edur ural al antib antibio ioti tics cs prio priorr to ESWL ESWL are are ther theref efore ore recommended.

1096 1096 G. R. R. Caddy Caddy and and T. T. C. K. Tham Tham

Practice points      

The success rate of duct clearance for retained bile duct stones using laser lithotripsy is between 64% and 97% but large randomised studies are lacking Laser lithotripsy may be more effective ESWL in clearing the bile duct of CBDS but larger studies are required Bile duct clearance rates are reported to be approximately 74% using EHL One study found no significant difference in the clearance rates of CBDS using either EHL or ESWL Complete duct clearance of CBDS following ESWL range between 83% and 93% The majority of patients will require endoscopic extraction of the bile stone fragments following lithotripsy, although approximately 10% of stones may subsequently pass spontaneously following treatment.

CHEMICAL DISSOLUTION THERAPY

Following published reports of chemical dissolution therapy for gallstones, the technique of chemical co contact ntact dissolution for retained common bile duct stones was first 102 published in 1947. However, due to the side effects of the chemical used (diethyl ether), the procedure was not widely practiced. The discovery of mono-octanoin as a cholesterol stone dissolving agent, led to several reports of its use in difficult to remove CBDS. Palmer and Hofmann collated a series of case case reports on its use in treating CBDS (most of these patients had not had previous sphincterotomy), and therapy was deemed ‘useful’ in 54% 54 % of patients. However, side effects were common and reported reported in 67% of patients. patients.103 The chemical is administered via a nasobiliary catheter, T-tube or percutaneous catheter and therapy is required for at least several weeks making therapy less practical. The use of methyl tertiary butyl ether (MTBE) has advantages over ov er othe otherr chem chemic ical al disso dissolu luti tion on agen agents ts,, mainl mainlyy that that of fast faster er kine kinetic tics. s. In a nonnonrandomised study by Neoptolemos and colleagues, MTBE was used in 33 patients with bile duct stones and found to be helpful helpful in removal in 36% of patients. Again complication rates were high (79%) in this study. 104 At present the use of chemical chemical dissolution therapy has a limited role in the treatment of difficult to remove CBDS due to the length of treatment, continuous access to the bile duct that is required and a high complication rate. SUMMARY

Symptomatic BDS commonly cause significant morbidity and attempt at stone removal should be attempted attempted if possible. possible. Complication Complicationss of CBDS include include biliary biliary colic, jaundice, cholangitis and pancreatitis. Investigations aimed to predict the presence of stones within the bile duct include serum bilirubin, AST, ALP, common bile duct diameter and age as independent predictors of choledocholithiasis. TUS is a sensitive test in detecting bile duct dilatation but the sensitivity is reduced in its ability to detect choledoch do chol olith ithia iasis sis.. A NIH NIH co cons nsen ensu suss stat statem emen entt foun found d that that ERC, ERC, MRC MRC and and EUS EUS we were re compar comparabl able e in their their sensiti sensitivit vities ies,, specific specificitie itiess and acc accura uracy cy rates rates for detect detection ion of 

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choledocholithiasis. ERC and stone removal using a balloon or basket is often performed following EST. EBD may be performed if patients have uncorrected coagulopathies but the risk of pancreatitis is higher than for EST (although the risk of bleeding complications is lower for EBD). ML is often required in difficult to remove CBDS and using this device, CBDS can be removed in 90 e95% of cases. Other forms of lithotripsy including laser lithotripsy and EHL are confined to specialised centres and the evidence for their use is based on small studies. ESWL may clear stones from the bile duct in up to 93% of patients but frequently ERC and stone fragment removal is required post ESWL. The role of medical therapy in difficult to remove CBDS (or in CBDS in patients with severe co-morbid illness preventing ERC þ stone removal) is still currently uncertain due to a lack of large randomised control trials.

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